The Effect of Therapeutic Ultrasound on Pain in Coccydynia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-07-01

Brief Summary

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Pain of the sacrococcygeal region is called coccydynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Physical therapy modalities are used in the treatment of coccydynia. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.Our aim in this study is to compare the effectiveness of continuous and intermittent ultrasound in patients with a diagnosis of coccydynia and to examine its effect on pain.

Detailed Description

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Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccydynia, the pain becomes continuous. Conservative treatment, interventional procedures and surgical treatment are used in treatment. Medical treatment, physical therapy and local injection applications are accepted as conservative treatment methods.Among the physical therapy modalities, ultrasound has been used for many years in diseases affecting the musculoskeletal system. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.

A total of 52 patients who applied between 01/04/2021 and 01/04/2022 and met the inclusion and exclusion criteria will be included in the study. Continuous ultrasound will be performed in 26 patients and intermittent ultrasound will be performed in 26 patients. Randomization will be determined by the treatment protocol prepared in closed envelopes.Within the scope of the study, the age, height, weight, trauma history, duration of complaint, severity of pain and Oswestry Disability Index scale will be recorded before the interventions. The patients will be followed up at the 3rd week and 3rd month after the treatment. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS).

Data will be entered into SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for data showing normal distribution, and non-parametric tests will be used for data not showing normal distribution. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P\<0.05 will be considered significant.

Conditions

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Coccyx Disorder

Keywords

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coccyx pain ultrasonic waves

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel groups will be received different treatment modalities

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent ultrasound

Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Intermittent ultrasound will be used as a physical therapy agent. Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes.

Group Type ACTIVE_COMPARATOR

Intermittent ultrasound

Intervention Type OTHER

Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Continuous ultrasound

Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Continuous ultrasound will be used as a physical therapy agent. Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes.

Group Type ACTIVE_COMPARATOR

Continuous ultrasound

Intervention Type OTHER

Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Interventions

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Intermittent ultrasound

Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Intervention Type OTHER

Continuous ultrasound

Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with coccydynia and having idiopathic or trauma history in etiology
* 18-75 years old
* The patient's acceptance of the ultrasound treatment to be applied
* Being in good mental health in terms of compliance with the treatment to be applied
* Receiving conservative treatment before ultrasound treatment
* The patient's numerical pain scale must be 5 and above

Exclusion Criteria

* Being under the age of 18 and over the age of 75
* The patient's refusal to accept the treatment
* Wound or soft tissue infection in the skin area to be treated
* Pregnant patients
* Patients who have been diagnosed with malignancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Emel Güler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emel Güler, MD

Role: PRINCIPAL_INVESTIGATOR

Cumhuriyet University

Locations

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Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emel Güler, MD

Role: CONTACT

Phone: +905356492951

Email: [email protected]

Özhan Pazarcı, MD

Role: CONTACT

Phone: +903224559000

Email: [email protected]

Facility Contacts

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Emel Güler, MD

Role: primary

References

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Haghighat S, Mashayekhi Asl M. Effects of Extracorporeal Shock Wave Therapy on Pain in Patients With Chronic Refractory Coccydynia: A Quasi-Experimental Study. Anesth Pain Med. 2016 Jun 1;6(4):e37428. doi: 10.5812/aapm.37428. eCollection 2016 Aug.

Reference Type BACKGROUND

PMID: 27843777 (View on PubMed)

Other Identifiers

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2021-02/29

Identifier Type: -

Identifier Source: org_study_id

The Effect of Therapeutic Ultrasound on Pain in Coccydynia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Intermittent ultrasound

Intermittent ultrasound

Continuous ultrasound

Continuous ultrasound

Interventions

Intermittent ultrasound

Continuous ultrasound

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Cumhuriyet University

Responsible Party

Emel Güler

Principal Investigators

Emel Güler, MD

Locations

Sivas Cumhuriyet University

Countries

Central Contacts

Emel Güler, MD

Özhan Pazarcı, MD

Facility Contacts

Emel Güler, MD

References

Haghighat S, Mashayekhi Asl M. Effects of Extracorporeal Shock Wave Therapy on Pain in Patients With Chronic Refractory Coccydynia: A Quasi-Experimental Study. Anesth Pain Med. 2016 Jun 1;6(4):e37428. doi: 10.5812/aapm.37428. eCollection 2016 Aug.

Related Links

Other Identifiers

2021-02/29